Originally featured in STAT News.
The pandemic served as a tipping point to advance decentralized clinical trials (DCTs) and other innovations in clinical trial management. To date, most of the innovation has centered around infrastructure and process—solving for the patient burdens and geographic barriers related to time, travel, and logistics. Meanwhile, there’s been much less innovation on the other side of the equation: patient recruitment, the linchpin of clinical research.
In these early days of DCTs, there’s been a general mindset of “if we build it, they will come.” However, there haven’t been corresponding efforts to get patients to come. We aren’t seeing many new education and awareness campaigns designed to target the historically hard-to-reach personas for which DCTs are primarily intended. Moreover, while trial designers often attempt to keep the patient experience top-of-mind, they frequently fall short due to the errant assumption that they already understand the patient rather than working through outreach to advocacy groups, trusted community providers, or the patients themselves.
There’s little argument that patient recruitment has historically been the single biggest challenge in drug development. If you've heard about any statistics surrounding clinical trial recruitment, it's most likely that approximately 80% of clinical trials are delayed or closed because of problems with recruitment. Additional statistics paint a troubling picture: Delays can cost sponsors between $600,000 and $8 million for each day that a trial delays a product’s development and launch. This last statistic alone points to why the pandemic shifted the use of DCTs from a nice-to-have efficiency gain to a financial risk management must-have.
Percent of clinical trials that are delayed or closed because of recruitment problems
$600,000 - $8 million
Cost to the sponsor per day that a trial delays product development and launch
Now that innovative digital technology and supporting processes have been deployed to support the paradigm shift to DCTs, recruitment tactics must also shift so that patients can realize the benefits from this increased access to novel treatments. To overcome historical barriers such as lack of awareness and education, safety stigmas, or fear of the unknown, what’s needed is a much more proactive, human-centered approach. In the same way that DCTs used, collated, and refined existing technology to drive innovation, a new wave of recruitment tactics can follow a similar path to innovation: applying existing marketing and education best practices focused on human-centered design.
To overcome historical barriers such as lack of awareness and education, safety stigmas, or fear of the unknown, what’s needed is a much more proactive, human-centered approach.
Meet Patients Where They Are
A human-centered approach focuses on understanding where people are and meeting them there—not just physically, but also mentally and emotionally. DCTs help solve for a portion of the physical part (~70 percent of potential patients live more than two hours away from existing study centers). What’s needed now is a targeted approach to meeting patients where they are mentally and emotionally to guide them through the process of finding, understanding and enrolling in a clinical trial.
The good news is there’s no need to reinvent the wheel. Recruitment efforts can take a page from marketing playbooks of other industries to adopt best practices—such as developing personas to understand the diverse set of patients desired to tailor messaging or participation options to them. Those personas can also guide the creation of new, trusted channels to inform, educate, and recruit a wider audience, including patients outside the reach of mainstream research sites.
Using trusted channels such as local doctors’ offices, community clinics, pharmacies, churches, workplaces or community organizations, can help overcome awareness and education barriers. Less than 50 percent of U.S. adults have ever heard of a clinical trial, and less than 43 percent have ever seen an advertisement for one, according to Statista. What’s more, building a network of local influencers within those channels can help overcome some of the misconceptions and trust issues that have hindered participation in the past.
Less than 50%
of U.S. Adults have ever heard of a clinical trial
Less than 48%
Of U.S. Adults have ever seen a clinical trial ad
Other industries have developed digital marketing best practices in awareness-building and lead conversion that can be adapted and applied to trusted channels as a way of meeting patients in a place that’s familiar to them both physically and digitally. Other healthcare sectors have started to do this and have also opportunistically used the pandemic to increase the personalization of content. For example, we’ve seen large retail pharmacy clients provide personalized healthcare/pharmacy suggestions based on location and recent customer activity by deploying mobile apps that provide push notifications related to COVID testing/vaccine services, pollen counts/allergy meds, etc.
Clinical trial sponsors have an opportunity to latch onto these trends and the recent clinical trial awareness caused by the COVID-19 vaccine trials to employ similar tactics.
Dissolve Barriers to Entry With Flexible Design
Disease groups are inherently heterogeneous; however, clinical trial populations typically are not (e.g., ~72 percent white), according to a report from the FDA. This disconnect highlights the challenge of recruiting a study population that matches the real world. A human-centered approach can help overcome this constraint by reaching, recruiting, and retaining a more diverse mix of potential participants.
Designing for flexibility and inclusion is integral to meeting patients where they are. By creating and applying diverse personas as outlined above, clinical trials can be designed in a way that’s inclusive to multiple personas—not just catering to the most common participant type. Using trusted channels to recruit, together with the new pathways to participation enabled by DCTs, can increase participation of patients with more diverse age, race and socioeconomic backgrounds.
Flexible experience design for both recruitment and on-study activities is essential to accessing this larger pool of patients—and retaining them once they’re on-study. Designing with flexibility in mind (e.g., offering both remote, digital visit options and in-clinic visits) is paramount because burdens related to travel, technology use, or in-home care will vary widely by persona. Many qualified patients will be excluded if protocols or study recruitment strategies are designed in an either/or manner.
Again, we can look to other industries for inspiration. For example, flexible design practices are common in product development best practices, yet they haven’t been applied to clinical trials.
To take this concept a step further, consider flipping the site/patient dynamic altogether by offering just-in-time clinical trials. This means creating a network of patients, and then opening a site near them or serving them virtually instead of the traditional route of opening a site first and hoping it can recruit patients. Turning the process on its head has many operational and regulatory hurdles, but to truly change the paradigm and expand beyond the investigator sites primarily located at large institutions, a transformational effort is likely required.
Support the Interrelated Needs of Stakeholders
Effective flexible design also requires careful consideration of impacts throughout the stakeholder ecosystem. And successful human-centered design requires studying the interrelated impacts on all stakeholders: patients, investigators, site staff, and study teams from sponsors or their clinical vendors.
To take this holistic, human-centered view, it’s useful to map the experience journey of the primary stakeholder (i.e., the patient) and link it to the stakeholders and technology serving that journey. This makes the connective impact of design decisions more visible, while minimizing any unintended consequences that could benefit one stakeholder at the expense of another.
Another human-centered design principle is that people need a sense of ownership to thrive. Considering the interrelated journeys of all stakeholders is a start. However, at this time of rapid change towards future-ready, patient-centric approaches, it’s important to recognize that many stakeholders in the pharmaceutical industry have traditionally resisted change. They can’t simply be mandated to adopt or deploy new technologies and practices; they need to be educated, trained, incentivized and given an iterative feedback loop in a way that facilitates ownership in a new clinical trial.
The Bottom Line
The pandemic has advanced innovations that are changing the way clinical trials are conducted. However, to truly realize the paradigm shift towards operational innovation that’s occurring within the life sciences industry, it’s time to co-opt human-centered design best practices from other industries and apply them to recruitment and retention strategies.